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Trial was stopped due to difficult enrolment
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This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A GRT3983Y | Experimental | Participants randomly assigned to receive GRT3983Y. |
|
| B Placebo | Placebo Comparator | Participants randomly assigned to placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRT3938Y | Drug | Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Intensity | The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16). | Baseline; last 7 days of 12-week maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance | Baseline, Daily scores over entire 12 week maintenance | |
| Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 127 | Fairhope | Alabama | United States | |||
| Site 130 |
503 participants were excluded from the trial before assignment to a treatment group because they did not meet the inclusion and or exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | GRT3983Y | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Overencapsulated tablets of placebo, 16 weeks treatment. |
|
| Baseline, Last 7 days of 12-week maintenance |
| Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance. | Baseline; daily scores over each week of maintenance |
| Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS). | Baseline; weekly mean |
| Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively. | Baseline, weekly mean |
| Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit). | Baseline, weekly mean |
| Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit) | Baseline, weekly mean |
| Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit). | Day 29, Day 71 and Day 113. |
| Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Baseline, Day 29, Day 71 and Day 113. |
| EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Baseline, Day 29, Day 71 and Day 113. |
| Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Baseline, Day 29, Day 71 and Day 113. |
| Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Baseline, Day 29, Day 71 and Day 113. |
| Time to Treatment Discontinuation Due to Lack of Efficacy. | Baseline to time to treatment discontinuation |
| Assessment of Rescue Medication Usage During the 4-week Titration. | 4-week titration phase |
| Homewood |
| Alabama |
| United States |
| Site 112 | Tucson | Arizona | United States |
| Site 129 | Escondido | California | United States |
| Site 209 | Fullerton | California | United States |
| Site 135 | Long Beach | California | United States |
| Site 202 | Northridge | California | United States |
| Site 208 | Northridge | California | United States |
| Site 219 | Northridge | California | United States |
| Site 203 | San Francisco | California | United States |
| Site 116 | Santa Ana | California | United States |
| Site 118 | Santa Ana | California | United States |
| Site 121 | Santa Ana | California | United States |
| Site 133 | Santa Ana | California | United States |
| Site 126 | Vista | California | United States |
| Site 214 | Vista | California | United States |
| Site 201 | Waterbury | Connecticut | United States |
| Site 136 | Deerfield Beach | Florida | United States |
| Site 137 | Deerfield Beach | Florida | United States |
| Site 140 | Deerfield Beach | Florida | United States |
| Site 216 | Deerfield Beach | Florida | United States |
| Site 217 | Deerfield Beach | Florida | United States |
| Site 218 | Deerfield Beach | Florida | United States |
| Site 117 | Fort Myers | Florida | United States |
| Site 124 | Jacksonville | Florida | United States |
| Site 228 | Jupiter | Florida | United States |
| Site 101 | Orlando | Florida | United States |
| Site 226 | Orlando | Florida | United States |
| Site 206 | Sarasota | Florida | United States |
| Site 212 | West Palm Beach | Florida | United States |
| Site 142 | Atlanta | Georgia | United States |
| Site 128 | Chicago | Illinois | United States |
| Site 223 | Chicago | Illinois | United States |
| Site 114 | Leawood | Kansas | United States |
| Site 102 | Paducah | Kentucky | United States |
| Site 211 | Baltimore | Maryland | United States |
| Site 108 | East Bridgewater | Massachusetts | United States |
| Site 113 | Las Vegas | Nevada | United States |
| Site 122 | Princeton | New Jersey | United States |
| Site 230 | New York | New York | United States |
| Site 109 | Rochester | New York | United States |
| Site 225 | Asheville | North Carolina | United States |
| Site 115 | High Point | North Carolina | United States |
| Site 227 | Canton | Ohio | United States |
| Site 233 | Cincinnati | Ohio | United States |
| Site 111 | Toledo | Ohio | United States |
| Site 125 | Toledo | Ohio | United States |
| Site 104 | Philadelphia | Pennsylvania | United States |
| Site 106 | Philadelphia | Pennsylvania | United States |
| Site 205 | Philadelphia | Pennsylvania | United States |
| Site 105 | Austin | Texas | United States |
| Site 213 | Corpus Christi | Texas | United States |
| Site 110 | Houston | Texas | United States |
| Site 123 | Houston | Texas | United States |
| Site 204 | Houston | Texas | United States |
| Site 210 | Houston | Texas | United States |
| Site 231 | Houston | Texas | United States |
| Site 131 | San Antonio | Texas | United States |
| Site 215 | San Antonio | Texas | United States |
| Site 221 | San Antonio | Texas | United States |
| Site 139 | Provo | Utah | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GRT3983Y | |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Pain Intensity | The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline; last 7 days of 12-week maintenance |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, Daily scores over entire 12 week maintenance |
|
| |||||||||||||||||||||||
| Secondary | Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, Last 7 days of 12-week maintenance |
|
| |||||||||||||||||||||||
| Secondary | Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance. | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline; daily scores over each week of maintenance |
|
| |||||||||||||||||||||||
| Secondary | Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline; weekly mean |
|
| |||||||||||||||||||||||
| Secondary | Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively. | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, weekly mean |
|
| |||||||||||||||||||||||
| Secondary | Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, weekly mean |
|
| |||||||||||||||||||||||
| Secondary | Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit) | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, weekly mean |
|
| |||||||||||||||||||||||
| Secondary | Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Day 29, Day 71 and Day 113. |
|
| |||||||||||||||||||||||
| Secondary | Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, Day 29, Day 71 and Day 113. |
|
| |||||||||||||||||||||||
| Secondary | EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, Day 29, Day 71 and Day 113. |
|
| |||||||||||||||||||||||
| Secondary | Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, Day 29, Day 71 and Day 113. |
|
| |||||||||||||||||||||||
| Secondary | Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline, Day 29, Day 71 and Day 113. |
|
| |||||||||||||||||||||||
| Secondary | Time to Treatment Discontinuation Due to Lack of Efficacy. | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | Baseline to time to treatment discontinuation |
|
| |||||||||||||||||||||||
| Secondary | Assessment of Rescue Medication Usage During the 4-week Titration. | Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial. | Posted | 4-week titration phase |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GRT3983Y | 2 | 27 | 15 | 27 | |||
| EG001 | Placebo | 1 | 23 | 14 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Diabetic ketoacidosis | Metabolism and nutrition disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hypoaesthesia | Nervous system disorders |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
|
No participants were analyzed as the study was terminated
It is the Institution and Principal Investigator's obligation not to publish any information declaration, invention or whatsoever which is in connection with this Agreement without the prior written consent of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Grünenthal | +49 (0)-241-569-3223 | clinical-trials@grunenthal.com |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D000377 | Agnosia |
| D009437 | Neuralgia |
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
| Male |
|